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MicrogravityBRAHMSNCT07499167

BRAHMS: Bed Rest And HypoMetabolism Study

A study testing head down bedrest and caloric restriction in people with Microgravity and Caloric Restriction, run by Centre National d'Etudes Spatiales at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this single arm, interventional monocentric clinical trial is to investigate the physiological effects of a combination of head-down bedrest and caloric restriction on the human body. Read more about this study

Who is it for?
Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Microgravity, Caloric Restriction
What is being tested?
head down bedrest and caloric restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteFrance
Study dates
10 Mar 2026to 28 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male volunteers (see below the description of medical tests and laboratory analysis performed at the selection visit)
  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination): in particular, free from any known chronic disease or any acute mood or eating disorder, infectious disease or cardiovascular, metabolic, neurological, ENT (especially orthostatic hypotension and vestibular disorders), orthopedic or musculoskeletal disorders.
  • 20 to 40 years old
  • 165 to 185 cm
  • Body Mass Index between 20 and 26 kg.m-2
  • Stable body weight in the past 3 months (less than 4% change)
Show all 15Show fewer
  • Fat Mass Index (FMI), defined as (bodyfat weigh in kg)/(height in m)2: between 3 and 6 kg.m-2, measured by whole-body DEXA
  • Triglyceride level under 1.7 mmol.L-1
  • Normal bone mass density at left hip and lumbar spine: T-score>-1.5, measured by DEXA
  • VO2peak/VO2max between 35 and 55 mL.min-1.kg-1
  • Non-smokers
  • No alcohol or drug dependence, no medical treatment on a regular basis
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC).
  • Free of any engagement during the study
  • Who agreed to take part in the study and signed the informed consent

Who cannot join

  • Any history or presence of clinically relevant chronic disease; any acute infectious disease. Particularly (but not limited to):
  • Symptomatic orthostatic hypotension whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within 3 minutes when changing from the supine to the standing position
  • Personal or family history of thrombosis, genetic mutation for factor V or prothrombin gene
  • Cardiac arrhythmia
  • Hypertension
  • Auto-immune diseases or Raynaud's syndrome
Show all 41Show fewer
  • History or symptoms of sleep apnea
  • Chronic back pains,
  • Vertebral fracture, scoliosis, or herniated disc,
  • Color-blindness,
  • Self-reported hearing problems or binocular visual acuity under 6/10 after correction
  • Vestibular disorders
  • Drug addiction
  • History of migraines,
  • History of hiatus hernia or gastro-esophageal reflux,
  • History of thyroid dysfunction or diabetes
  • History of head trauma,
  • History of neurological diseases (e.g. epilepsy)
  • History of genetic muscle and bone diseases of any kind
  • Significant history of allergies
  • Significant abnormality in blood tests
  • Positive serology for hepatitis A, hepatitis B, hepatitis C or AIDS (HIV) virus
  • Mood and Eating disorder (current or past), screened with the Hospital Anxiety Depression Scale (HADS), SCOFF (Sick, Control, One, Fat, Food) and the Eating Disorder Examination Questionnaire (EDE-Q)
  • Antibiotics exposure 2 months prior to the study
  • Major lifestyle changes (e.g. significant weight/body changes, diet or exercises regimen) 6 months prior to the study
  • Specific diet (e.g vegan, carnivore, intermittent fasting, dietary supplements consumption)
  • History of hypocaloric diet, judged as significant by the investigator
  • Subject who, in the judgment of the investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development,
  • Subject in the exclusion period of another clinical research,
  • Subject who received 6000 Euros or more within 12 months for being a research subject,
  • Poor tolerance to blood sampling,
  • Subject who cannot be contacted in case of emergency,
  • Contraindications for MRI: claustrophobia, presence of osteosynthesis material or metal implants,
  • Blood donation of more than 7 ml/kg in the 8 weeks prior to the start of the study,
  • Vulnerable people according to law "Code de la Santé Publique" (L1121-5 to L1121-8):
  • Pregnant or nursing women (urine pregnancy test for women of childbearing potential)
  • People deprived of their liberty by an administrative or judicial decision
  • People under involuntary psychiatric care
  • People admitted in a health or social establishment for purposes other than research
  • Minors
  • Adults subject to legal protection (subject under guardianship or trusteeship) or unable to express their consent

Trial locations and contacts

1 site in 1 country.

France1 site
  • Medes - Imps

    Toulouse, Medes-imps, 31400

Other trials in France

About this study

Official title: BRAHMS: Bed Rest And HypoMetabolism Study Integrative Physiological Responses to 10 Days of Bedrest and Caloric Restriction: An Exploratory Pilot Study In 10 Healthy Men.

The goal of this single arm, interventional monocentric clinical trial is to investigate the physiological effects of a combination of head-down bedrest and caloric restriction on the human body. A set of measurements will assess the changes in the musculoskeletal, cardiovascular, hematological, immune, neurological, cognitive and metabolic systems, in 10 healthy male volunteers.

The main question it aims to answer is: what are the physiological responses to fasting in a microgravity environment?

Read more

In an exploratory study such as this one, where many physiological systems are explored, it is difficult to select a single important endpoint. However, given the known effect of both caloric restriction and head-down bedrest on muscle loss, and its critical importance for the success of space missions, lean body mass, as assessed by DEXA, was chosen as the primary endpoint.

The secondary endpoints are:

  • Cardiovascular, muscular, neuro-vestibular and neuropsychological functional performance
  • The onset of clinical symptoms and biological changes

Participants will be exposed to a microgravity analog model (head down bed rest) and controled caloric restriction environment for 10 days, multiple physiological assessments will be performed during this period. Followed by a rehab period before leaving the study.

Being tested
head down bedrest and caloric restriction
Keywords
Microgravity, Caloric restriction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • head down bedrest and caloric restrictionOther

    the intervention is 10 days of head down bedrest (-6°) and controlled and progressive caloric restriction, then controlled and progressive refeeding

Study groups in NCT07499167
Study groupRoleWhat they receive
Caloric restrictionExperimentalhead down bedrest and caloric restriction (250 kcal/day)
Receives: Other: head down bedrest and caloric restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean Body Mass

    Lean Body Mass assessed by dual energy x-ray absorptiometry (DEXA)

    Measured: At baseline, during the ten days of intervention and until 90 days after the end of the intervention

Secondary outcomes (36)
  1. Change in body fluid compartments by bioelectrical impedance analysis

    Extracellular, intracellular and total body water (L) will be estimated by bioimpedance

    Measured: At baseline, during the ten days of intervention and until 90 days after the end of the intervention

  2. Change in whole-body Magnetic Resonance Imaging (MRI)

    Change in MRI-measured whole-body Lean mass (kg) and Fat mass (kg) will be estimated

    Measured: At baseline and at day 9 of intervention period

  3. Change in mood

    Change in mood is assessed using the Profile of Mood States (POMS) questionnaire. POMS questionnaire gives 6 measures of mood: Tension/anxiety, Depression, Anger/hostility Dynamism, Fatigue, Confusion A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative subscales (tension, depression, fatigue, confusion, anger) and then subtracting the totals for the positive subscale (vigor /esteem-related affect).

    Measured: At baseline, during the ten days of intervention and until 4 days after the end of the intervention

  4. Assessment of movements by volunteers

    Actigraphs attached to wristbands placed on the non-dominant wrist and ankle of each volunteer

    Measured: At baseline, during the ten days of the intervention and until 4 days after the end of the intervention

  5. Change in cardiovascular deconditioning and orthostatic tolerance (stand test)

    This test continuously measures heart rate (bpm) via a Finapres device while subjects sit for 5 minutes, then stand for 10 minutes and then sit again for 5 minutes

    Measured: At baseline and 1 day after the end of intervention period

  6. Changes in orthostatic tolerance

    Orthostatic tolerance will be assessed during a tilt test combined with Lower Body Negative Pressure test (LBNP test)

    Measured: At baseline and 1 day after the end of intervention period

  7. Changes in peak aerobic power (VO2max test)

    Exercise capacity wil be assessed by graded cycling on sitting ergometer until exhaustion

    Measured: At baseline and 4 days after the end of intervention period

  8. Changes in plasma volume

    Plasma volume (L) will be assessed by the Dill \& Costill method

    Measured: At baseline, during the ten days of the intervention and until 4 days after the end of the intervention

  9. Change in long term blood pressure

    This test continuously measures Blood Pressure during 24 hours with the SOMNOTouch device.

    Measured: At baseline, during the 10 days of the intervention, and 4 days after the end of the intervention

  10. Change in macrocirculation

    Macrocirculation will be assessed using standard ultrasound measurements at the carotid and femoral levels (arteries and veins).

    Measured: At baseline, during the 10 days of the intervention, and at 3 days after the end of the intervention

  11. Change in endothelial function

    The tests consists in the measurement of the variations of the brachial artery diameter as a response to shear stress.

    Measured: At baseline, during the 10 days of the intervention, and 3 days after the end of the intervention

  12. Myofiber atrophy evaluation

    Biopsy sampling from m. vastus lateralis will be performed to measure structure and function of muscle fibers.

    Measured: At baseline and at day 9 of intervention

  13. Changes in jump performance

    Jump performance will be assessed on a platform and height of the jump will be evaluated

    Measured: At baseline and 1 day after the end of the intervention

  14. Change in protein metabolism

    Labeled tracers (¹³C leucine for oxidation, ¹⁵N-phenylalanine for degradation, ²H₅-phenylalanine for synthesis monitoring and NaH13CO3 for quantification of amin acid oxidation) will be infused to the volunteers, and blood, urine, muscle and breath samples will be collected.

    Measured: At baseline and at day 9 of the intervention

  15. Change in muscle strength

    Muscle strength will be assessed via dynamometry

    Measured: At baseline and 2 days after the end of the intervention

  16. Change in bone biological marker

    Measuring bone-specific Alkaline Phosphatase (bAP) in blood

    Measured: At baseline, during the ten days of intervention and until 90 days after the end of the intervention

  17. Changes in bone density (by High Resolution Peripheral Computed Tomography (HR-pQCT))

    Bone density (g/cm2) is measured at tibia and radius level with HR-pQCT.

    Measured: At baseline and until 90 days after the end of the intervention

  18. Changes in Resting Metabolic Rate (RMR)

    RMR will be measured by indirect calorimetry technique

    Measured: At baseline, during the ten days of intervention and until 90 days after the end of the intervention

  19. Change in nitrogen balance

    Nitrogen balance is a measure of nitrogen input minus nitrogen output. Nitrogen intake is calculated with a nutrition software. Protein oxidation measured in the 24-Hour urine collection estimates nitrogen output.

    Measured: At baseline, during the ten days of intervention and at 90 days after the end of the intervention

  20. Change in metabolic flexibility (Oral Glucose Tolerance Test (OGTT))

    Metabolic flexibility will be measured during OGTT to assess the ability of the body to adjust energy substates' availability.

    Measured: At baseline and 4 days after the end of the intervention.

  21. Change in glucose homeostasis

    Continuous measurement of interstitial glucose concentration by Dexcom sensor

    Measured: From baseline to day 5 after the end of the intervention

  22. Change in energy expenditure of tissues and organs (by PET-scan)

    Regional mapping of metabolic activity by dynamic PET-scan with ¹⁸F-fluorodeoxyglucose

    Measured: At baseline and at day 7 of the intervention period

  23. Metabolic change in adipose tissue

    Histology, cell culture, adipocyte size distribution and whole adipose tissue transcriptome, proteome, lipidome and metabolome on adipose tissue biopsy

    Measured: At baseline and at day 9 of the intervention

  24. Change in gut microbiota

    Gut microbiome, metabolome and proteome will be measured in stool samples

    Measured: At baseline, during the ten days of the intervention and 4 days after the end of the intervention period

  25. Modification of self perceived hunger

    Questionnaires about self-perceived hunger will be delivered before and after breakfast, lunch, snack, and dinner, or at the equivalent times on the fasting days. The questionnaire consists of a Visual Analogue Scale on which the volunteer must indicate their level of hunger (from 'not at all' to 'extremely')

    Measured: At baseline, during the ten days of the intervention and until 4 days after the end of the intervention period

  26. Change in energy requirements

    Change in energy requirements using water labeled with a stable oxygen isotope (H218O)

    Measured: At baseline and at day 9 of the intervention period

  27. Change in motor function (Sit-to-stand test)

    Sit-to-stand test : volunteer will be requested to rise as fast as possible from a chair without using hands and stand for 10s. The following parameter will be measured : Settling time after standing.

    Measured: At baseline and 1 day after the end of the intervention period

  28. Change in standing balance

    This test assesses standing balance on a platform covered with 12-cm thick medium density foam.

    Measured: At baseline and 1 day after the end of the intervention period

  29. Change in vestibular health

    Battery of tests will be used to asses vestibular health: recovery from fall, path integration, distance perception, perception of self-rotation, how long 1', Posner task, antisaccade task

    Measured: At baseline and 1 day after the end of the intervention period

  30. Change in cognitive state

    This test monitor changes in the subject's emotional state and executive function by evaluatingpsychotechnical tasks on a laptop (the neurosensorybox) with physiological sensors (SOMNO HD system).

    Measured: At baseline, during the ten days of the intervention period and at day 5 after the end of the intervention

  31. Salivary cortisol evolution

    To characterize stress level, morning and evening salivary cortisol (ng/ml) will be assessed

    Measured: At baseline, at day 1, 3 & 10 of intervention period, and day 4 after the end of the intervention

  32. Change in memory performance

    Subjects are exposed to a series of images that will have to be remembered. After a delay of 1 hour or 24 hours they will be questioned on a series of images presented under the same conditions and they will have to indicate in a grid whether these images are known or new

    Measured: At baseline, during the ten days of the intervention period, and until 3 days after the end of the intervention

  33. Change in the internal representation of 3D space

    This tests consist in a rhythmic point-to-point hand movements in virtual reality.

    Measured: At baseline, during the ten days of the intervention period, and until 3 days after the end of the intervention

  34. Change in gastro-brain interaction

    Assessment of the correlation between gastric electrical activity (measured via Electrogastrography) and neural oscillatory responses (measured via Electroencephalography) during a cognitive task

    Measured: At baseline, during the ten days of the intervention period, and until 4 days after the end of the intervention

  35. Change in motor function (Walk and turn test)

    Walk and turn test : volunteer will be instructed to walk as quickly as possible straight ahead toward a cone walk around it and return to the chair. Completion time per walk-and-turn trial will be measured.

    Measured: At baseline and 1 day after the end of the intervention period

  36. Change in motor function (Tandem Walk)

    Tandem walk : Volunteer will walk 10 heel-to-toe steps with their arms folded across their chests and their eyes closed (3 trials) followed by one trial with their eyes open. Percentage of correct steps will be measured.

    Measured: At baseline and 1 day after the end of the intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start10 Mar 2026
  3. Primary completion28 Sep 2026 (estimated)
  4. Study completion28 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499167
Sponsor's protocol ID
25-369
Acronym
BRAHMS
Status last verified
Jul 2026
First submitted
27 Feb 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing head down bedrest and caloric restriction in people with Microgravity and Caloric Restriction, run by Centre National d'Etudes Spatiales at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean Body Mass (time frame: At baseline, during the ten days of intervention and until 90 days after the end of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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